- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01489631
Analgesia After Total Knee Replacement Surgery
Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery
Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome.
Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design:
Prospective randomised study
Study population:
Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study.
Intervention:
The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. The second group will receive local infiltration with ropivacaine of the knee during surgery. Half of these patients will additionally be treated with gabapentin.
Primary study parameters/outcome of the study:
NRS-score (11-scale Numeric Rating Scale in which 0 means no pain, and 10 means most pain imaginable) in rest.
Secondary study parameters/outcome of the study:
Speed of mobilisation, postoperative opiate consumption. NRS scores during flexion exercise of the knee and during walking exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nieuwegein, Netherlands, 3430 EM
- St. Antonius Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older and legally responsible
- Waiting for total knee replacement surgery
- Informed consent
Exclusion Criteria:
- Contraindications for epidural analgesia
- Aortic Valve stenosis
- Severely compromised cardiac function
- infection near epidural punction site
- Redo knee surgery
- Previous arthrotomies
- Allergy/Hypersensitivity for study mediation or all other used medication
- Participation in other studies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: epidural analgesia
The first group will be treated with epidural analgesia.
Before surgery the epidural catheter will be placed according to local guidelines.
After the operation epidural infiltration with bupivacaine and sufentanil will be commenced.
|
bupivacaine 0,125%
Other Names:
sufentanil 1mcg/ml
Other Names:
|
ACTIVE_COMPARATOR: local infiltration
The second group will receive local infiltration with ropivacaine of the knee during surgery.
|
ropivacaine 0,2%, 3x 50 ml during surgery
Other Names:
|
ACTIVE_COMPARATOR: local infiltration and gabapentin
The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin.
|
ropivacaine 0,2%, 3x 50 ml during surgery
Other Names:
gabapentin 600 mg pre-operative 3 dd 300 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NRS score in rest
Time Frame: 3 days after surgery
|
3 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speed of mobilisation
Time Frame: 3 days after surgery
|
3 days after surgery
|
|
Postoperative morphine consumption
Time Frame: 3 days after surgery
|
Daily morphine consumption (mg) per day
|
3 days after surgery
|
NRS score during flexion exercise
Time Frame: 3 days after surgery
|
3 days after surgery
|
|
NRS score during walking exercise
Time Frame: 3 days after surgery
|
3 days after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leon Timmerman, MD, Anesthesiologist
- Principal Investigator: Louis N Marting, MD, Orthopedic Surgeon
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- Anticonvulsants
- Anesthetics, Local
- Antimanic Agents
- Gabapentin
- Bupivacaine
- Ropivacaine
- Sufentanil
Other Study ID Numbers
- TKP-37796
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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